GRAS Notice (GRN) No. 599 http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/NoticeInventory/default.htmGR 11111111111111111111 ORIGINAL SUBMISSION 000001 . Tox Innovative solutions Sound science September 3, 2015 Richard E. Bonnette, M.S. Office of Food Additive Safety (HFS-200) Center for Food Safety and Applied Nutrition Food and Drug Administration 5100 Paint Branch Parkway College Park, MD 20740-3835 Subject: GRAS Notification- Citrus Fiber (CitriTex® citrus fiber) Dear Mr. Bonnette: In response to your email of August 25, 2015 and our recent telephone conversation, I am resubmitting the Citrus fiber GRAS Notification on behalf of Cargill, Incorporated. ToxStrategies, Inc. (its agent) is submitting, for FDA review, Form 3667 and three copies of the GRAS notification as required. We have removed all redactions or reference to confidential business information that existed in the previously submitted documents. The enclosed document provides notice of a claim that the food ingredient, CitriTex® citrus fiber described in the enclosed notification is exempt from the premarket approval requirement of the Federal Food, Drug, and Cosmetic Act because it has been determined to be generally recognized as safe (GRAS), based on scientific procedures, for addition to select foods as a texturizer and moisture retention agent. Ifyou have any questions or require additional information, please do not hesitate to contact me at 630-352-0303, or g~~J¥11i!t@tQ21,§l!::~!~g_i~~&QJ1.!. Sincerely, (b) (6) Don Schmitt, M.P.H. Senior Managing Scientist SEP 4 2015 OFFICE OF FOOD ADDITIVE SAFETY ToxStrategies, Inc .. 739 Thornapple Dr .. Naperville, IL 50650 Office (630) 352-0303 • WW\v.toxstrategies.com 000002 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration GENERALLY RECOGNIZED AS SAFE (GRAS) NOTICE Transmit completed form and attachments electronically via the Electronic Transmit completed form and attachments in paper format or on physical media to: Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835. PART I-INTRODUCTORY INFORMATION ABOUT THE SUBMISSION 1. Type of Submission (Check one) IZJ New D Amendment to GRN No. D Supplement to GRN No. 2. D All electronic files included in this submission have been checked and found to be virus free. (Check box to verify) 3a. For New Submissions Only: Most recent presubmission meeting (if any) with FDA on the subject substance (wwlmmldd): 3b. For Amendments or Supplements: Is your (Ci?eck one) amendment or supplement submitted in DYes If yes. enter the date of response to a communication from FDA? D No communication (yyyy/mm!dd): ------- PART II-INFORMATION ABOUT THE NOTIFIER Name of Contact Person Position Ms. Witty Brathwaite Senior Scientist Company (if applicable) 1a. Notifier Cargill, Incorporated Mailing Address (number and street) 15407 McGinty Road West City State or Province Zip Code/Postal Code Country Wayzata !Minnesota I 55391 United States of America Telephone Number Fax Number E-Mail Address 647-464-8081 [email protected] Name of Contact Person Position Donald F. Schmitt Senior Managing Scientist 1b.Agent Company (if applicable) or Attorney (ifapplicable) ToxStrategies, Inc. Mailing Address (number and street) 739 Thornapple Drive City State or Province Zip Code/Postal Code Country Naperville IIllinois I 60540 United States of America Telephone Number Fax Number E-Mail Address 630-352-0303 dsch m itt@toxstrateg ies.com FORM FDA 3667 (2/13) Page 1 of 5 000003 PART Ill- GENERAL ADMINISTRATIVE INFORMATION 1. Name of Substance Citrus fiber 2. Submission Format: (Check appropriate box(es)) 3. For paper submissions only: 0 Electronic Submission Gateway D Electronic files on physical media Number of volumes 1 [gJ Paper with paper signature page If applicable give number and type of physical media Total number of pages 128 4. Does this submission incorporate any information in FDA's files by reference? (Check one) [gJ Yes (Proceed to Item 5) 0 No (Proceed to Item 6) 5. The submission incorporates by reference information from a previous submission to FDA as indicated below (Check all that apply) [gJ a) GRAS Notice No. GRN 487 0 b) GRAS Affirmation Petition No. GRP 0 c) Food Additive Petition No. FAP 0 d) Food Master File No. FMF 0 e) Other or Additional (describe or enter information as above) GRNs 541,154,525,478,430,427,373,344,342,310,261,213 6. Statutory basis for determination of GRAS status (Check one) [gJ Scientific Procedures (21 CFR 170.30(b)) 0 Experience based on common use in food (21 CFR 170.30(c)) 7. Does the submission (including information that you are incorporating by reference) contain information that you view as trade secret or as confidential commercial or financial information? 0 Yes (Proceed to Item 8) [gJ No (Proceed to Part IV) 8. Have you designated information in your submission that you view as trade secret or as confidential commercial or financial information (Check all that apply) 0 Yes, see attached Designation of Confidential Information 0 Yes. information is designated at the place where it occurs in the submission 0No 9. Have you attached a redacted copy of some or all of the submission? (Check one) D Yes. a redacted copy of the complete submission D Yes, a redacted copy of part(s) of the submission D No PART IV- INTENDED USE 1. Describe the intended use of the notified substance including the foods in which the substance will be used, the levels of use in such foods, the purpose for which the substance will be used, and any special population that will consume the substance (e.g., when a sub­ stance would be an ingredient in infant formula, identify infants as a special population). CitriTex® citrus fiber is intended for use as a texturizer and moisture retention agent in select foods. Cargill intends to use citrus fiber (CitriTex® citrus fiber) as a texturizer and moisture retention agent in yogurt, low-fat mayonnaise, ice cream, ice pops and sorbet (use levels not to exceed 4%), and processed meat and poultry products (use levels not to exceed 5%), in accordance with current good manufacturing practices (cGMP). The amount used will not exceed the amount reasonably required to accomplish its intended technical effect 2. Does the intended use of the notified substance include any use in meat, meat food product, poultry product, or egg product? (Check one) [gJ Yes FORM FDA 3667 (2113) Page 2 of 5 000004 Registry Biological Source Name of Substance 1 Used Registry No.2 (if applicable) (CAS, EC) citrus fiber (cellulose, hemicellulose, and pectin) lemon, lime, and orange peels 2 3 1lnclude chemical name or common name. Put synonyms (whether chemical name, other scientific name, or common name) for each respective item (1 - 3) in Item 3 of Part V (synonyms) 2 Registry used e.g., CAS (Chemical Abstracts Service) and EC (Refers to Enzyme Commission of the International Union ofBiochemistry (IUB), now carried out by the Nomenclature Committee of the International Union of Biochemistry and Molecular Biology (IUBMB)) Description Provide additional information to identify the notified substance(s), which may include chemical formula(s), empirical formula(s), structural formula(s), quantitative composition, characteristic properties (such as molecular weight(s)), and general composition of the substance. For substances from biological sources, you should include scientific information sufficient to identify the source (e.g., genus, species, variety, strain, part ofa plant source (such as roots or leaves), and organ or tissue of an animal source), and include any known toxicants that could be in the source. Citrus fiber is manufactured to meet the specifications on page 13 in Table 2. ilable or relevant: CitriTex"' citrus fiber 2 3 FORM FDA 3667 (2/13) Page 3 of 5 000005 PART VI- OTHER ELEMENTS IN YOUR GRAS NOTICE (check list to help ensure your submiSSion IS complete- check all that apply) [gJ Any additional information about identity not covered in Part V of this form [gJ Method of Manufacture [gJ Specifications for food-grade material [gJ Information about dietary exposure [gJ Information about any self-limiting levels of use (which may include a statement that the intended use of the notified substance is not-self-limiting) 0 Use in food before 1958 (which may include a statement that there is no information about use of the notified substance in food prior to 1958) [gJ Comprehensive discussion of the basis for the determination of GRAS status [gJ Bibliography Other Information Did you include any other information that you want FDA to consider in evaluating your GRAS notice? [gJ Yes 0 No Did you include this other information in the list of attachments? [gJ Yes 0No PART VII- SIGNATURE 1. The undersigned is informing FDA that Cargill, Incorporated (name of notifier) has concluded that the intended use(s) of Citrus fiber ----------------------~0-am-e~of~n~ot~ffle-d~s-oo~s~m-n-re~)------------------------------ described on this form, as discussed in the attached notice, is (are) exempt from the pre market approval requirements of section 409 of the Federal Food, Drug, and Cosmetic Act because the intended use(s) is (are) generally recognized as safe. 2. [gJ Cargill, Incorporated agrees to make the data and information that are the basis for the (name of notifier) determination of GRAS status available to FDA if FDA asks to see them. Cargill, Incorporated agrees to allow FDA to review and copy these data and information during ---=--'---__.:..._______________________ customary business hours at the following location if FDA asks to do so. (name ofnotifier) 15407 McGinty Road West, Wayzata, MN 55391 (address ofnotifier or other location) _C_a...:rg:.-i....:ll,_l_nc_o_r..:...p_o_ra_t'-e"'"d::::-::-:<:O=::-::;-------------- agrees to send these data and information to FDA if FDA asks to do so.